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CDSCO Manufacturing License for Electronic epidural space locator control unit

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Introduction

The Central Drugs Standard Control Organization (CDSCO) serves a vital role in preserving healthcare quality in India by ensuring that drugs and medical devices available to the public meet the highest standards of safety and effectiveness. As the national regulatory body, CDSCO is responsible for granting regulatory approvals in the form of licenses to manufacturers and distributors of pharmaceuticals and medical equipment on the Indian market.

Manufacturing licenses are paramount in the medical device industry. They serve as proof that a manufacturer has met all legal and safety requirements and that their products are fit for sale and use. An essential part of ensuring the safety and effectiveness of medical devices is understanding and working within the regulatory framework of CDSCO.

Let's delve into understanding the intricacies involved in procuring a manufacturing license for the Electronic epidural space locator control unit. The CDSCO portal provides an array of resourceful information on medical device regulations and licenses, and it can be accessed here.

What is an Electronic Epidural Space Locator Control Unit?

An Electronic Epidural Space Locator Control Unit is a sophisticated medical device used in anaesthesia administration procedures. Specifically, it aids healthcare professionals in locating the epidural needle tip within the epidural space during anaesthesia administration. The device ensures precision during procedure, thereby enhancing patient safety and improving the outcomes of the anaesthesia administration process.

The Role of CDSCO in Medical Device Regulation

The CDSCO is the apex regulatory body responsible for medical device regulation in India. Its mission is to safeguard and enhance public health by ensuring the safety, efficacy, and quality of medical devices distributed on the Indian market. The regulatory framework of CDSCO encompasses a broad range of medical devices, and the Electronic Epidural Space Locator Control Unit falls under this purview.

How to Manufacture the Electronic Epidural Space Locator Control Unit

The manufacturing of an Electronic Epidural Space Locator Control Unit is a meticulous process that requires precision and adherence to a set of regulations laid out by the CDSCO. Detailed information on the device specifications and the manufacturing process is necessary for the application of a manufacturing license.

Fees for the Manufacturing License for Electronic Epidural Space Locator Control Unit

As the Electronic Epidural Space Locator Control Unit is classified as a Class D risk device, the relevant license is MD9. The licensing fee for the MD9 is Rs. 50,000 for the license, in addition to Rs. 1,000 per product.

Why is a Manufacturing License Necessary for an Electronic Epidural Space Locator Control Unit?

Obtaining a manufacturing license is mandatory under the purview of the regulatory bodies in charge of ensuring quality and safety in the production of medical devices. Apart from being a legal requirement, a manufacturing license also validates the quality, safety, and efficacy of the device. Having a license issued by CDSCO enhances consumer trust and protects patients from substandard products.

Steps to Obtain a CDSCO Manufacturing License for an Electronic Epidural Space Locator Control Unit

  1. Pre-requisites: Certificate of Quality Management System (ISO13485), Device Master File, Device Details, Site Details, manufacturing process information and more.
  2. Application submission at CDSCO; electronic submissions considered.
  3. Evaluation of the application by CDSCO; communication of recommendations or requests for additional information.
  4. Final approval and issuance of the manufacturing license.

More in-depth information on obtaining the MD9 license can be found here.

Frequently Asked Questions (FAQs)

Q1. What is the risk class of an Electronic Epidural Space Locator Control Unit as per Medical Device Rules, 2017?

The Electronic Epidural Space Locator Control Unit is classified as a Class D risk device.

Q2. What license is needed to manufacture an Electronic Epidural Space Locator Control Unit?

To manufacture an Electronic Epidural Space Locator Control Unit, an MD9 license is required.

Q3. What is the fee for the MD9 license for an Electronic Epidural Space Locator Control Unit?

The licensing fee for the MD9 is Rs. 50,000 for the license, to which Rs. 1,000 per product is added.

Q4. Who will issue the manufacturing license for the Electronic Epidural Space Locator Control Unit?

The CDSCO Headquarters in New Delhi is responsible for issuing the manufacturing license for the Electronic Epidural Space Locator Control Unit.

Q5. Is repackaging of the Electronic Epidural Space Locator Control Unit considered manufacturing?

Yes. As per the Drugs and Cosmetics Act's definition of manufacturing, repackaging of drugs is manufacturing, and by extension, medical devices, which are also considered drugs. Therefore, repackaging of an Electronic Epidural Space Locator Control Unit requires a license - in this case, the MD9.

Conclusion

Acquiring a manufacturing license can seem like a daunting task, especially when you have to navigate through regulations, documents, fees, and classes of medical devices. However, you don't have to face these complexities alone.

Reach out to Pharmadocx Consultants for expert advice and assistance regarding the licensing process. You can also call us directly at +91-7404557227 or email us at [email protected]. Leveraging our expertise, we can guide you through every step of the process, simplifying the procedure and ensuring the best outcomes. Don't hesitate to get in touch!

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